SCULPTRA and SCULPTRA Aesthetic (injectable poly-L Lactic acid)
FDA premarket approval P030050/S033 · decided 2020-12-18
Approval details
- PMA number
- P030050
- Supplement
- S033
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SCULPTRA and SCULPTRA Aesthetic (injectable poly-L Lactic acid)
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2020-11-18
- Decision date
- 2020-12-18
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Addition of an alternate sterilization site for the flip-off seal used for Sculptra and Sculptra Aesthetic products.
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